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<eudamedExport entity="devices">
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    <udiDi>00863840000278</udiDi>
    <basicUdiDi>B-00863840000278</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (50 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00055</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:05.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863840000261</udiDi>
    <basicUdiDi>B-00863840000261</basicUdiDi>
    <tradeName>AmplideX DM1 Dx Kit</tradeName>
    <deviceName>AmplideX DM1 Dx Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010118</emdnCode>
    <emdnDescription>MYOTONIC DYSTROPHY TYPE 1 OR STEINERT'S DISEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:01.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863840000230</udiDi>
    <basicUdiDi>B-00863840000230</basicUdiDi>
    <tradeName>QuantideX qPCR BCR-ABL minor Kit</tradeName>
    <deviceName>QuantideX qPCR BCR-ABL minor Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49640</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:00.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850017493049</udiDi>
    <basicUdiDi>B-00850017493049</basicUdiDi>
    <tradeName>AmplideX mPCR FMR1 Test</tradeName>
    <deviceName>AmplideX mPCR FMR1 Test</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:20.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850017493032</udiDi>
    <basicUdiDi>B-00850017493032</basicUdiDi>
    <tradeName>AmplideX HTT SNP/Repeat Phasing Test</tradeName>
    <deviceName>AmplideX HTT SNP/Repeat Phasing Test</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010107</emdnCode>
    <emdnDescription>HUNTINGTON CHOREA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00083</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850017493025</udiDi>
    <basicUdiDi>B-00850017493025</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (100 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00056</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850017493124</udiDi>
    <basicUdiDi>0850017493A011248A</basicUdiDi>
    <tradeName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A01124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:36.652Z</lastUpdated>
  </row>
</eudamedExport>